Breast CancerPhase 2NCT06000033
Study of Disitamab Vedotin and Anlotinib in Patients With HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer
A Phase 2 study testing Disitamab Vedotin+Anlotinib in people with Breast Cancer, run by Qilu Hospital of Shandong University.
Trial summary
Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker , which is the first ADC drug that was independently developed by Rongchang Biology .The aim of this study is to evaluate the efficacy and safety of RC48 in Combination with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Disitamab Vedotin+Anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1)At the time of signing the informed consent form, the age is ≥ 18 years old, regardless of gender;
- 2)Patients with pathohistologically proven, locally advanced or metastatic breast cancer have progressed through second-line standard treatment;
- 3)The immunohistochemical (IHC) test results of archived tissue (within 6 months) or fresh biopsy lesions were negative for ER and PR, while patients with low HER-2 expression were HR -, HER2IHC1+, or HER2IHC2+and ISH negative;
- 4)ECOGPS: 0-1 points;
- 5)Expected survival time\>12 weeks;
- 6)Adequate organ function: bone marrow function: hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5 × 109/L; White blood cell count ≥ 3.0 × 109/L; Platelets ≥ 100 × 109/L; Liver function: serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); Aspartic acid Transaminase (AST) and alanine Transaminase (ALT) ≤ 3.0 × ULN (or ≤ 5.0 in the presence of liver metastasis) × ULN) Renal function: blood creatinine ≤ 1.5 × The creatinine clearance rate (CrCl) calculated by ULN or Cockcroft Fault formula method is ≥ 60mL/min; Cardiac function: New York Heart Association (NYHA) grading\<3; Left ventricular Ejection fraction ≥ 50%;
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- 7)At least one measurable lesion defined in RECIST version 1.1;
- 8)Women of childbearing age must have taken reliable contraceptive measures or conducted a Pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test and 8 weeks after the last administration of the test drug. For males, it is necessary to agree to use appropriate methods of contraception or undergo surgical sterilization during the trial period and 8 weeks after the last administration of the investigational drug;
- 9)The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation in follow-up.
Who cannot join
- 1)The second-line treatment within 3 months is paclitaxel drug therapy;
- 2)Received antitumor therapy or radiation therapy for any malignancy within the previous five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma;
- 3)had a major non-breast cancer related surgery in the 4 weeks prior to enrollment, or had not fully recovered from such surgery;
- 4)Previously received ADC drugs, anti-angiogenesis drugs, anti-HER2 and other treatments;
- 5)Serious cardiovascular and cerebrovascular disease or discomfort, including but not limited to the following diseases: - History of confirmed heart failure or systolic dysfunction (LVEF<50%) - high-risk uncontrolled arrhythmias - angina, acute myocardial infarction - clinically significant valvular heart disease - poorly controlled hypertension (systolic blood pressure >180mmHg and/or diastolic blood pressure >100mmHg)
- 6)known allergic history of the drug components of this protocol;
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- 7)A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
- 8)symptomatic brain metastases or brain metastases (excluding prophylactic cranial irradiation) within 4 weeks prior to initiation of treatment; 9) Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or patients of childbearing age who were unwilling to take effective contraception throughout the trial period;
- 9)Have a serious concomitant condition or other comorbid condition that interferes with planned treatment, or any other condition in which the investigator deems the patient unsuitable for participation in the study.
About this study
Official title: Combination of Disitamab Vedotin and Anlotinib in the Treatment of HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer: A Single-Arm, Multicenter, Phase II Clinical Study
Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker , which is the first ADC drug that was independently developed by Rongchang Biology .The aim of this study is to evaluate the efficacy and safety of RC48 in Combination with Anlotinib for the treatment of metastatic breast cancer with HR negativity and HER2 low expression.
- Conditions
- Breast Cancer
- Being tested
- Disitamab Vedotin+Anlotinib
- Keywords
- HER2 low expression, Breast Cancer, RC48, Disitamab Vedotin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disitamab Vedotin+AnlotinibDrug
Disitamab Vedotin:2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days.
| Study group | Role | What they receive |
|---|---|---|
| RC48+Anlotinib | Experimental | Disitamab Vedotin : 2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days. Receives: Drug: Disitamab Vedotin+Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The percentage of cases that have achieved complete or partial remission after drug treatment compared to the total evaluable cases.
Measured: 1year
Secondary outcomes (5)
Progression-Free Survival (PFS)
All adverse events (AEs) in this study will be encoded using MedDRA and classified according to the NCICTCAEv5.0 grading system.
Measured: 2years
Overall Survival (OS)
Defined as the time from the beginning of the patient's treatment to death from any cause.
Measured: 2years
Disease Control Rate (DCR)
The proportion of patients who achieve complete remission (CR), partial remission (PR), or disease stability (SD) during or after treatment
Measured: 1year
Duration of Response (DOR)
Defined as the date from which tumor remission was first recorded (evaluated according to the RECIST 1.1 standard) to the date when disease progression was first recorded (evaluated according to the RECIST 1.1 standard) or the date of death from any cause.
Measured: 1year
AEs
All adverse events (AEs) in this study will be encoded using MedDRA and classified according to the NCICTCAEv5.0 grading system.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start10 Aug 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000033
- Sponsor's protocol ID
- RC48HR-/HER2LOW
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Disitamab Vedotin and Anlotinib in the Treatment of HR-Negative, HER2-Low-Expressing Metastatic Breast Cancer: A Single-Arm, Multicenter, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06000033
- Acronym / sponsor ID
- RC48HR-/HER2LOW
- Conditions
- Breast Cancer
- Keywords
- HER2 low expression, Breast Cancer, RC48, Disitamab Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Disitamab Vedotin (RC48) contains the novel humanized anti-HER2 antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable linker , which is the first ADC drug that was independently developed by Rongchang Biology .The aim of this study is to evaluate the efficacy and safety of RC48 in Combination with Anlotinib for the treatment of metastatic breast cancer with HR negativity and HER2 low expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RC48+Anlotinib | Experimental | Drug: Disitamab Vedotin+AnlotinibDisitamab Vedotin : 2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1)At the time of signing the informed consent form, the age is ≥ 18 years old, regardless of gender;
- 2)Patients with pathohistologically proven, locally advanced or metastatic breast cancer have progressed through second-line standard treatment;
- 3)The immunohistochemical (IHC) test results of archived tissue (within 6 months) or fresh biopsy lesions were negative for ER and PR, while patients with low HER-2 expression were HR -, HER2IHC1+, or HER2IHC2+and ISH negative;
- 4)ECOGPS: 0-1 points;
- 5)Expected survival time\>12 weeks;
Key exclusion criteria (9 listed)
- 1)The second-line treatment within 3 months is paclitaxel drug therapy;
- 2)Received antitumor therapy or radiation therapy for any malignancy within the previous five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma;
- 3)had a major non-breast cancer related surgery in the 4 weeks prior to enrollment, or had not fully recovered from such surgery;
- 4)Previously received ADC drugs, anti-angiogenesis drugs, anti-HER2 and other treatments;
- 5)Serious cardiovascular and cerebrovascular disease or discomfort, including but not limited to the following diseases: - History of confirmed heart failure or systolic dysfunction (LVEF<50%) - high-risk uncontrolled arrhythmias - angina, acute myocardial infarction - clinically significant valvular heart disease - poorly controlled hypertension (systolic blood pressure >180mmHg and/or diastolic blood pressure >100mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disitamab Vedotin+AnlotinibDisitamab Vedotin:2 mg/kg，ivgtt，d1-14/28day/cycle Anlotinib: 12mg once daily (taken before meals) orally, continuously for 2 weeks followed by a 1-week break. Each cycle consists of 21 days. | Drug | RC48+Anlotinib |
Primary outcome
Objective response rate (ORR)
Time frame: 1year
The percentage of cases that have achieved complete or partial remission after drug treatment compared to the total evaluable cases.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2years
Overall Survival (OS)
Time frame: 2years
Disease Control Rate (DCR)
Time frame: 1year
Duration of Response (DOR)
Time frame: 1year
AEs
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disitamab Vedotin+Anlotinib in people with Breast Cancer, run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.